Device Classification Name |
stent, ureteral
|
510(k) Number |
K013921 |
Device Name |
PORGES SILICONE DOUBLE LOOP URETERAL STENT, MODEL # AJ4X / BJ1X / BJ2X |
Applicant |
PORGES S.A. |
CENTRE D'AFFAIRES |
LA BOURSIDIERE |
LE PLESSIS ROBINSON CEDEX,
FR
92357
|
|
Applicant Contact |
BERNARD ISMAEL |
Correspondent |
PORGES S.A. |
CENTRE D'AFFAIRES |
LA BOURSIDIERE |
LE PLESSIS ROBINSON CEDEX,
FR
92357
|
|
Correspondent Contact |
BERNARD ISMAEL |
Regulation Number | 876.4620
|
Classification Product Code |
|
Date Received | 11/27/2001 |
Decision Date | 10/17/2002 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
Gastroenterology/Urology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|